(87 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning and evaluation tools.
No.
The document explicitly states that Oncentra Prostate is a "software application" and a "real time' treatment planning system." It provides tools for planning and evaluating brachytherapy treatments, not the treatment itself.
No
Explanation: The device is a 'treatment planning system for brachytherapy' which provides anatomical and dosimetric information to determine source positioning and loading, and assists in generating dose distribution. These functions are related to treatment planning and delivery, not diagnosis.
No
The device description explicitly states it is a "real time" treatment planning system that uses direct 3D ultrasound imaging of the implant to update the treatment plan. While the core functionality is software, it is intrinsically linked to and dependent on hardware (the ultrasound imaging system) for its real-time operation and input data. It is not a standalone software application that operates independently of external hardware for its primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Oncentra Prostate is a software application used for treatment planning in brachytherapy procedures. It uses imaging data (ultrasound, CT, MR) to help physicians determine the placement and loading of radioactive sources for treating prostate cancer.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on planning and guiding a medical procedure based on imaging and anatomical information.
Therefore, Oncentra Prostate falls under the category of a medical device used for treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Oncentra Prostate is a software application for brachytherapy treatment planning, for the treatment of cancer (i.e. intercavitary, interstitial, intraluminal) involving radioactive sources.
Oncentra Prostate is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources The software should only be used by a person trained in brachytherapy techniques (such a person will be referred to as the user).
Product codes
JAQ
Device Description
Oncentra Prostate is a "real time" treatment planning system for brachytherapy, specially designed for the treatment of prostate cancer. Direct 3D ultrasound imaging of the implant gives the possibility to update the treatment plan during insertion of the catheters in the prostate. Before treatment, the software provides the physician with anatomical and dosimetric information, which is used to determine the positioning and loading of radioactive sources. The software also provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution (e.g. dose verification at a point and dose volume histograms).
The features of the Oncentra Prostate software depend on the installed modules, as shown in the following table:
Module: Oncentra Prostate - Basic Module
Key Features: Full screen user interface Template calibration and alignment Manual VOI definition Manual and automatic catheter placement, taking into account VOIs Manual catheter reconstruction Auto-activation of dwell positions within VOI Manual (de)activation of dwell positions Manual editing of dwell weights and times Optimization techniques: geometric optimization, optimization on dose points Optimization history for evaluation Evaluation tools: cumulative DVH, differential DVH Multiple graphical tools Configuration customization file Output: printer, afterloader system, preview plot
Module: Oncentra Prostate - SmoothBase
Key Features: Patient administration User management
Module: Oncentra Prostate - 3D Ultrasound
Key Features: 3D ultrasound acquisitions together with stepper encoder positioning system Selectable frame to frame step size Stepper encoder controlled volume navigation 3D isodose surface Resize volume of interest
Module: Oncentra Prostate - Auto recognition of catheters
Key Features: Automatic catheter recognition on US image (requires 3D ultrasound)
Module: Oncentra Prostate - Auto contouring
Key Features: Automatic VOI contouring based on 3 slices contours Automatic VOI contouring based on base contours and a 3D path Automatic 2D VOI contouring based on US image detection
Module: Oncentra Prostate - Inverse Planning
Key Features: Multi-objective anatomy-based optimization Multi-objective DVH-based optimization Decision tools
Module: Oncentra Prostate – RT-HDR William Beaumont
Key Features: Anatomic placement of catheters using customizable parameters according to the William Beaumont Hospital method
Module: Oncentra Prostate – CT/MR and advanced optimizations
Key Features: Planning on CT and MR modality Import of VOIs and plans of different modalities Hybrid catheter reconstruction on CT Volume evaluation Temporary availability of up to 10 volumes of different modalities 3D display of surface and volume with clipping DVH shaper Plan comparison (multiple plans) HIPO inverse planning
Module: Oncentra Prostate – Color US (Doppler)
Key Features: Support of color US imaging for acquisition and planning
Module: Oncentra Prostate – Fusion for all modalities
Key Features: Volume fusion and registration of two volumes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (3D, Color Doppler), CT, MR
Anatomical Site
Prostate (for prostate cancer treatment)
General cancer sites (intercavitary, interstitial, intraluminal) involving radioactive sources.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
A person trained in brachytherapy techniques (referred to as the user).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Non- clinical testing: All relevant hazards were analyzed and appropriate measures were verified. Verification and validation was performed according Nudetron's procedures. Dose calculation was validated against reference standards in the same way as dose calculations of the predicate devices were validated. Oncentra Prostate 4.0 functions conform its specifications, is safe and effective for its intended use and performs as well as or better than its predicate devices.
Summary of Clinical testing: Clinical testing was not required to demopstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
NOV 1 8 20
August 20
Image /page/0/Picture/3 description: The image shows the Nucletron logo. The logo consists of a black circle with two white circles on the left side, followed by the word "Nucletron" in black bold letters. Below the word "Nucletron", there is the phrase "Improving patient care" in a smaller, cursive font.
Nucletron Corporation 7021 Columbia Gateway Drive Suite 200 Columbia, MD 21046-2133 U.S.A. 410-312-4100 Phone Fax 443-769-1570
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
Submitter of 510(k):
Company name: Registration number: Address:
Phone: Fax: Correspondent:
Nucletron Corporation 1121753 7021 Columbia Gateway Drive Columbia, MD 21046-2133 410-312-4100 443-7697546 Michael Paul, Quality Assurance & Regulatory Affairs Manager August 10, 2011
Date:
New Device Name:
| Trade/Proprietary Name: | Oncentra Prostate 4.0 |
|---|---|
| Common/Usual Name: | Treatment Planning System for Radiation Therapy |
| Classification Name: | System,Planning,Radiation Therapy Treatment |
| Classification: | 21Cfr892.5050 Class II |
Legally Marketed Device(s)
Our modified device is based on the legally marketed device cited in the table below:
| Manufacture | --------
1846 15 2012 2012 2017 2014
.
1
Device
11 40 | 510/7 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Nucietron BV | Shot
ﺎ ﺍﻟﻤﺴﺎ | - דרימח/ י |
| Nucletron BV
1 | " Swift " " | K031158 |
1
Device description:
Oncentra Prostate is a "real time" treatment planning system for brachytherapy, specially designed for the treatment of prostate cancer. Direct 3D ultrasound imaging of the implant gives the possibility to update the treatment plan during insertion of the catheters in the prostate. Before treatment, the software provides the physician with anatomical and dosimetric information, which is used to determine the positioning and loading of radioactive sources. The software also provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution (e.g. dose verification at a point and dose volume histograms).
The features of the Oncentra Prostate software depend on the installed modules, as shown in the following table:
| Module | Key Features |
|---|---|
| Oncentra Prostate - | |
| Basic Module | Full screen user interface Template calibration and alignment Manual VOI definition Manual and automatic catheter placement, taking into account VOIs Manual catheter reconstruction Auto-activation of dwell positions within VOI Manual (de)activation of dwell positions Manual editing of dwell weights and times Optimization techniques: geometric optimization, optimization on dose points Optimization history for evaluation Evaluation tools: cumulative DVH, differential DVH Multiple graphical tools Configuration customization file Output: printer, afterloader system, preview plot |
| Oncentra Prostate - | |
| SmoothBase | Patient administration User management |
| Oncentra Prostate - | |
| 3D Ultrasound | 3D ultrasound acquisitions together with stepper encoder positioning system Selectable frame to frame step size Stepper encoder controlled volume navigation 3D isodose surface Resize volume of interest |
| Oncentra Prostate - | |
| Auto recognition of | |
| catheters | Automatic catheter recognition on US image (requires 3D ultrasound) |
| Oncentra Prostate - | |
| Auto contouring | Automatic VOI contouring based on 3 slices contours Automatic VOI contouring based on base contours and a 3D path Automatic 2D VOI contouring based on US image detection |
| Oncentra Prostate - | |
| Inverse Planning | Multi-objective anatomy-based optimization Multi-objective DVH-based optimization Decision tools |
2
Traditional 510(k) Nucletron Oncentra Prostate 4.0
| Module | Key Features |
|---|---|
| Oncentra Prostate – | |
| RT-HDR William | |
| Beaumont | • Anatomic placement of catheters using customizable parameters |
| according to the William Beaumont Hospital method | |
| Oncentra Prostate – | |
| CT/MR and advanced | |
| optimizations | • Planning on CT and MR modality |
| • Import of VOIs and plans of different modalities | |
| • Hybrid catheter reconstruction on CT | |
| • Volume evaluation | |
| • Temporary availability of up to 10 volumes of different modalities | |
| • 3D display of surface and volume with clipping | |
| • DVH shaper | |
| • Plan comparison (multiple plans) | |
| • HIPO inverse planning | |
| Oncentra Prostate – | |
| Color US (Doppler) | • Support of color US imaging for acquisition and planning |
| Oncentra Prostate – | |
| Fusion for all modalities | • Volume fusion and registration of two volumes |
Intended use:
Oncentra Prostate is a software application for brachytherapy treatment planning, for the treatment of cancer (i.e. intercavitary, interstitial, intraluminal) involving radioactive sources.
Comparison with predicative devices
Oncentra Prostate 4.0 has the same intended use and the same scientific technology as its predecessor Swift 2.0 (K031158). Planning functionality for seeds is added and uses the same scientific technology as the predicate device Spot Pro (K022741).
Summary of Non- clinical testing
All relevant hazards were analyzed and appropriate measures were verified. Verification and validation was performed according Nudetron's procedures.
Dose calculation was validated against reference standards in the same way as dose calculations of the predicate devices were validated.
Oncentra Prostate 4.0 functions conform its specifications, is safe and effective for its intended use and performs as well as or better than its predicate devices.
Summary of Clinical testing
Clinical testing was not required to demopstrate substantial equivalence.
Name: John Lapre
Aug. 12 2011
Date
Name: John Lapre
Title: Vice President Research & Development
Nucletron B.V.
Veendaal, The Netherlands
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 8 2011
Mr. Michael Paul Regulatory Affairs/Quality Assurance Manager Nucletron Corporation 7021 Columbia Gateway Drive. Suite 200 COLUMBIA MD 21046-2133
Re: K112420
Trade/Device Name: Oncentra Prostate 4.0 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 20, 2011 Received: August 23, 2011
Dear Mr. Paul:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number